FDA.reportPublic FDA data

Application 206416

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEINJECTABLE;INTRAVENOUSEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-317Palonosetron HydrochloridePalonosetron HydrochlorideMylan Institutional LLCANDACurrent
67457-317Palonosetron HydrochloridePalonosetron HydrochlorideMylan Institutional LLCANDACurrent